The present invention is directed to a mouthpiece for use with a diagnostic instrument such as an endoscope. Endoscopy and other medical procedures require that an expensive instrument which includes relatively fragile components be inserted, via a patient's mouth, into the patient's body cavity.
Endoscopes and other types of medical instruments include fragile internal mechanisms which are contained in a tube. When inserting an instrument such as an endoscope into a patient's mouth, it is important to prevent damage to the endoscope and the patient. When tubes are inserted, patients will tend both reflexively and deliberately to bite on the tube. Such biting may damage the internal components of the instrument.
In performing procedures such as endoscopy, it is desirable to make the procedure as comfortable as possible for the patient. It is also important to insure that any device which contacts the patient is free from cross contamination from infectious diseases. One way of providing for freedom from cross contamination is to employ single-use devices. However, for practical reasons, single-use devices must be relatively inexpensive. To insure that single-use devices are not reused, it is helpful to have an easily ascertained indication of any prior use of the device.
It is known in the art to insert an endoscope or other device through a mouth guard or a mouthpiece which has previously been inserted in the patient's mouth. The mouthpiece insures that the patient's jaws are kept open a sufficient distance to permit insertion of the instrument and further protect the instrument from damage. Many of these prior art mouthpieces have been made of a rigid material since their primary purpose has been to protect the instrument. However, the rigidity of the mouthpiece results in discomfort to the patient and in possible injury to the patient from biting down on the rigid material. Further, as with any object inserted into the mouth, the mouthpieces tend to cause a gagging response in the patient if the mouthpiece is too large.
One example of a mouth guard designed to both protect a patient as well as the diagnostic instrument is disclosed in United States Letters Pat. No. 4,640,273 issued on Feb. 3, 1987 to Franklin R. Greene et al. The '273 patent discloses a mouth guard having a rigid core to protect the endoscope and a relatively flexible coat to cushion the patient's bite and thus protect the patient. The '273 mouth guard in use is neither rigid enough to adequately protect the instrument or compressible enough to provide adequate patient comfort. Further, the mouth guard extends too far into the patient's mouth to sufficiently avoid a gagging response.
It is an object of the present invention to provide a mouthpiece which protects both the instrumentation passed therethrough and the patient.
Another object of the present invention is to provide such a mouthpiece which is relatively inexpensive to manufacture.
Still a further object of the present invention is to provide such a simple mouthpiece which can be easily used and which is safe in use.
Still a further object of the present invention is to provide such a mouthpiece which is relatively comfortable and which doesn't cause gagging.
Another object of the present invention is to provide such a mouthpiece which will indicate if the mouthpiece has been used previously.